Two days workshop on
Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI's
Date: Thursday, 23 March 2017 - Friday, 24 March 2017 | Location: Orlando, FL | Download Workshop Brochure
Course Description
This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years' experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.

During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, filing for both Medical Device Reports (MDR) and eMDR, effective and appropriate communication with the appropriate regulatory agencies in the event of a recall and how UDI's factor into reporting. She will discuss, all the new FDA Guidance's that have issued in 2016 discussing FDA's thoughts on firms processes for MDR Reporting, a correction and removal action to avoid a recall crisis, including required recordkeeping, expectation from an FDA perspective on achieving regulatory compliance. In addition, she will provide key factors in implementing and maintaining compliance with the regulations from real life experiences of FDA.

Medical Device Reporting (MDR) and the implementation of the Final Rule on eMDR and recall compliance are critical to the continued survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. Ineffective or lack of proper Complaint Handling is cited as one of the top violations in a 483 issued at time of inspection by FDA. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required. This course will provide an understanding of MDR and Final Rule on eMDRs & recall compliance and the interrelationship of Complaint Handling, CAPA and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.

Learning Objectives:
  • Understand how to comply with complicated Compliant Handling, MDR, eMDR and Recall requirements
  • Firms eMDR/ MDR reporting and FDA's handling of reports and UDI requirements for recalls
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Navigating the maze of New Draft and Final FDA’s Guidance’s with Post-compliance issues
Who will Benefit
  • Quality Assurance and Quality Control personnel responsible complaint handling and recalls
  • Regulatory and Compliance professionals responsible for FDA interactions
  • Project Managers responsible for maintenance of Complaint Handling, troubleshooting, and understanding QSR
  • Risk Managers
  • CAPA Teams
  • Complaint handling units
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Regulatory/legislative affairs professionals
  • IT department supporting complaint handling
  • Regulatory affairs reporting units

Conference Day One (8:30 AM - 5:00 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start: 9:00 AM

Introduction to class (20 min)

Complaint Handling and FDA Expectations (70 min)
  • What is a complaint?
  • Firms Responsibilities and Definitions
    • Complaint Forms
  • FDA Expectations for written procedures on complaint files
Medical Device Reporting Procedures (MDR) (60 min)
  • Understand the MDR regulation 21CFR 803
  • Definitions 21 CFR 803.3
  • MDR Procedures 21 CFR 803.17
  • Discussion on 2016 Final Guidance
  • Types of MDR reports
  • MDR reporting by firm, agents and exemptions
MDR FDA Perspective (30 min)
  • CDRH Mandatory vs. Voluntary Reporting
  • What happens to an MDR report submitted to FDA
  • Manufacturer and User Facility Device Experience (MAUDE)
    • Medical Products Safety Network (MedSun)
    • eMDR Final Rule (45 min)
    • Final Rule
    • What is eMDR System
    • Highlights of Process
    • Options
    • Steps for acceptance of submission
User Error Malfunction
  • Identifying a Malfunction
  • Malfunction -To report or not to report
  • Serious injury triggers
  • Person Qualified Makes Medical Judgment
Recalls: Definitions and Legal Authority (45 min)
  • What is a recall?
  • Legal Authority (Chapter 7, 21CFR 806)
  • Voluntary vs. Mandatory recalls
  • Definitions - Corrections, Removals
  • Reporting requirements for non-recall field actions
  • Classification system - Classifying a Recall?
  • What is different about Class 1 recall
Being Recall Ready -Proactive Steps to Avoid Crisis (45 min)
  • Internal Decision Making
  • Early warning signs
  • authority
  • Examples of Close-calls
  • Guidelines and best practices for having contingency plan in place
Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)
  • Analyzing adverse event and product quality reports
  • Identifying trends, Data and factors to consider
  • Assessing need to conduct HHE
  • HHE Procedures
  • Human Factors Issues
  • Opening a CAPA to Determine Root Cause
Afternoon Wrap-up (30 min)
Conference Day Two (8:30 AM -3:00 PM)

Corrective and Preventive Action System (CAPA) (30 min)
  • What is a CAPA?
  • Essentials of and Effective System
  • Investigation and Steps to finding Root Cause
  • Root Cause Analysis
Elements of Correction and Removal Report (806.10) (50 min)
  • What must be reported
  • Construction of 806.10 Report
  • UDI information
  • How to provide Missing Information
  • Exemptions, Expanded Recall
  • Recordkeeping and Retention
Developing effective Strategies and Communicating with FDA (80 min)
  • Elements of a good Recall Strategy
  • What does the FDA expect strategy to contain?
  • Effective Notification Letter to minimize consequences
  • Knowing when to contact FDA District
  • Discussing Recall Strategy with FDA - Seeking input and support of your strategy to avoid common pitfalls
  • Issuance of Press Release and communication with customers
Notification Letters and Press Releases (45 min)
  • Firm’s Requirements
  • Common Mistakes
  • Constructing a Clearly Formatted Notification
  • Follow-up Communications
Silent Recalls vs. Product Enhancements and Enforcement by FDA (30 min)
  • Device changing environment
  • Product improvement (Repair or Modification)
  • Decision 803 or 806
Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
  • Receiving and accounting for returned products
  • Supply chain challenges - distribution, wholesale, repackaging
  • Global recall market
  • Designing an efficient Effectiveness Checks
  • Coordination and Discussion with FDA
  • Evaluating recall effectiveness Data
  • Developing and formatting status reports
Termination of a Recall (15 min)
  • Who, how and when does termination happen
  • Exporting a Recalled Product
  • Communication between firm and District Office
  • Requesting formal closeout by FDA
Mock Recall and Wrap-up (35 min)

Rita Hoffman, RAC - Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief

Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.

Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS' Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.

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Orlando, FL


Aloft Orlando Downtown

500 South Orange Avenue, Orlando, FL 32801

Local Attractions :
Walt Disney World

Everyone will turn a kid when you are at the Walt Disney World. Plunge into the world of cartoon with six Disney Parks, two exciting night-time entertainment districts, and a state-of-the-art sports complex. Experience over 20 themed disney resort hotels, plus countless opportunities for dining, recreation and shopping. No wonder Disney parks are the most sorted out holiday destination in the world.
SeaWorld Orlando

Connect to the ocean at SeaWorld, experience the power and grace of killer whales in the awe-inspiring Shamu show, One Ocean. Orcas jump skyward, dancing fountains dot the water, and a Splash Zone seat gives you submerged views of killer whales flapping their fins to drench you with water. Want more thrills? Take a ride at the Manta flying roller coaster that tilts you parallel to the ground and sends you headfirst on a twisting, plunging trip that starts with an inverted nosedive. Get closer to the penguins at the Antarctica/ Empire of the Penguin, a no-glass penguin exhibit.

Experience tones of fun and excitement at the Universal Orlando Resort which has two epic theme parks and best on-site hotels. Here you can enjoy gravity-defying, hair-raising thrills at Universal's Islands of Adventure. The key attractions include the Wizarding World of Harry Potter, the Amazing Adventures of Spider-Man and escape the jaws of a T-rex on the Jurassic Park River Adventure. Join the battle on transformers: the Ride-3D, and be transformed into a Minion on the 3D ride Despicable Me Minion Mayhem.
Basilica of the National Shrine of Mary

This popular 56,000 square foot Basilica includes an outdoor chapel, a Rosary Garden, bookstore and much more. The Basilica holds many unique architectural features including a 12 foot bronze work sculpted by Jerzy Kenar entitled 'Mother & Child' and a magnificent 650-pound replica of the Crucified Christ hanging over the main altar. The museum also depicts a beautiful art work depicting the Blessed Virgin Mary as well as a relic: a bone from the forearm of Saint Desiderius. The Shrine is open from 7:30 a.m. to 5:00 p.m daily.
Orlando Science Center

The Orlando Science Center encourages learning the fun way. This is the perfect place for educational activity, fun and knowledge all under one roof. The Science Center holds several branches of science from mechanics to biology and applied technology. Among the variety of themed exhibits, the most popular one is the 'Kids Town'. Kids Town is available to children under 48 inches tall with stimulating interactive exhibits.

Aquatica Orlando is one-of-a-kind water park that brings the most exhilarating underwater experience. Float through an undersea world of colorful fish, slide through a tube speeding through a lively lagoon filled with playful, black and white Commerson's dolphins. Aquatica's signature specialty includes the world's only side-by-side wave pools capable of operating both together and independently, while two winding rivers offer different voyages ranging from relaxing to racing. Omaka Rocka water slide is also sure to thrill you with its high-speed tubes and half-pipe funnels that'll have you splashing and sliding frontward and backward and climbing the walls.
Kennedy Space Center

Kennedy Space Center Visitor Complex (SM) is a must visit for all science enthusiasts. This is the place where NASA made history by first sending humankind from earth to explore the heavens. Touch a moon rock, walk under the largest rocket ever flown, meet an actual astronaut, and glimpse the future of space exploration at Kennedy space center. The Visitor Complex admission allows you to experience real Space Shuttle Atlantis at close vicinity, see an actual Saturn V moon rocket up-close, enjoy a variety of 3D space films in our twin IMAX theaters and experience the thrill of lift-off in Shuttle Launch Experience. The center opens daily at 9 a.m.

Gatorland welcomes you to the world of Alligators. This 110-acre theme park and wildlife preserve is filled with fascinating exhibits, electrifying rides and thrilling gator-themed entertainment. Enjoy the 1,200 feet of zip lines for the whole family, participate in 'rookie' gator wrestling for young visitors, climb an observation tower, take a train ride through the park and step inside an aviary. Also check out for the rare 'white' alligators at the park.